Source Document Specialist
Core
Support Study Coordinators in clinical trials by obtaining source documentation, managing medical records, and ensuring adherence to GCP and ICH regulations.
Role type
Clinical trial operations specialist (source document management)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Healthcare / Oncology / Clinical Research
Required skills
Source document retrieval, Medical record management, GCP compliance, ICH guidelines, Regulatory term knowledge, Spreadsheet management, Query resolution assistance
Preferred skills
Oncology experience, Clinical trials support, Pharmaceutical industry experience, Bachelor Degree
Technologies
Electronic health records (implied), Spreadsheets
Responsibilities
Obtain source documentation for enrolled patients, Assist with case report form completion, Assist with query resolution, Maintain and archive study administrative files, Create accountability spreadsheets for medical records, Work with external medical record departments and archives, Assess adherence to SOPs and regulations
Seniority
Mid-level, hands-on IC